The Lead Quality Assurance Specialist role is a key technical leadership position supporting GMP compliance, CAPA processes, and continuous improvement initiatives within the QA environment. The successful candidate will oversee the electronic Quality Management System, provide governance and oversight of deviations, investigations, and change controls, and mentor the QA team in developing robust quality processes. They will also lead internal audits, develop quality metrics, and contribute to inspection readiness, ensuring that GMP standards are maintained and improved through a pragmatic, risk-based approach.
- Proven experience within a GMP-regulated environment, especially in QA and CAPA processes
- Strong knowledge of Pharmaceutical Quality Systems and deviation management
- Experience managing electronic QMS systems (preferably Q-Pulse)
- Track record leading internal audits and root cause analysis
- Ability to develop and deliver quality process training
- Excellent stakeholder management and coaching skills
Offering a highly competitive benefits package, the company provides 33 days holiday (including public holidays), private health cover, a contributory pension scheme, life assurance, and a Christmas bonus equivalent to two weeks’ pay. Additional benefits include profit share bonuses, wellbeing programs, and sick pay, making this an excellent opportunity for an experienced GMP QA professional to develop their career within a supportive and rewarding environment.